iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB), (AVTX) – The Daily Biotech Pulse: Lilly Strikes Neurological R&D Collaboration, Valneva Confirms Vaccine Timelines, Biohaven Gains On Strong Migraine Drug Sales




Here’s a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Illumina Announces Co-Development Partnership With SomaScan For Accelerating Proteomics

Illumina, Inc. (NASDAQ: ILMN) announced it has entered into a definitive co-development agreement with SomaLogic to bring the SomaScan Proteomics Assay onto Illumina’s current and future high throughput next-generation sequencing platforms.

This partnership accelerates the rapidly growing high throughput sector of the proteomics market. With the scale and speed of Illumina NGS technology, researchers can more effectively and efficiently make biological connections from genetic sequence to cellular function and accelerate opportunities for clinical impact, Illumina said.

Lilly Announces R&D Collaboration With Entos To Develop Neurological Drug

Eli Lilly and Company (NYSE: LLY) said it has acquired exclusive rights to Entos Pharmaceuticals’ Fusogenix nucleic acid delivery technology to research, develop and commercialize nucleic acid products targeting the central and peripheral nervous system.

Under the terms of agreement, Lilly and Entos have agreed to multiple programs focused on the development of proteo-lipid vehicles for delivery of therapeutic cargo supplied by Lilly to targets in the central and peripheral nervous systems.

Entos will receive an initial payment of $50 million, which includes an equity investment by Lilly in Entos. For each of the programs under the collaboration, Entos is also eligible to receive up to $400 million in potential developmental and commercial milestone payments, as well as royalties upon the successful development and commercialization of products.

Sutro Biopharma Reports Positive Phase 1 Data For Antibody-Drug Conjugate In Ovarian Cancer

Sutro Biopharma, Inc. (NASDAQ: STRO) announced updated data from the Phase 1 study of STRO-002, an antibody-drug conjugate, for patients with advanced ovarian cancer, which showed that as of the Nov. 8 cut-off date, seven patients had achieved partial responses, five patients had unconfirmed partial responses and the overall response rate was 33% in all evaluable patients.

The stock was slipping 10.78% to $13 in premarket trading.

Related Link: The Week Ahead In Biotech (Jan 2-Jan. 8): Stray Clinical Readouts In Focus In Slow News Week

ObsEva Announces Mixed Late-Stage Data For Linzagolix In Endometriosis

ObsEva SA (NASDAQ: OBSV) announced positive topline results from the Phase 3 EDELWEISS 3 trial of linzagolix in women with moderate-to-severe endometriosis-associated pain.

The 200 mg once-daily dose of linzagolix in combination with add-back therapy met the coprimary endpoints as well as secondary endpoints, while the 75 mg dose of linzagolix without ABT did not meet the efficacy co-primary endpoint.

The stock was gaining 2.43% to $2.11 in premarket trading.

Freeline Gets FDA Clearance to Commence Phase 1/2 Study Of Gene Therapy To Treat Gaucher Disease Type 1

Freeline Therapeutics Holdings plc (NADASQ: FRLN) announced that the U.S. Food and Drug Administration has cleared its Investigational new drug application for FLT201 as an investigational gene therapy for the treatment of Gaucher disease Type 1.

The stock was surging up 44.39% to $2.83.

Valneva Confirms Vaccine Timelines, Continues To Expect Regulatory Nod In Q1

Valneva SE (NASDAQ: VALN) confirmed the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

The company said it has commenced rolling submissions for initial approval of VLA2001 with the European Medicines Agency, the U.K. MHRA and the Bahraini NHRA, and is continuing to work closely with those authorities to complete their review process following its positive Phase 3 trial results.

It continues to expect potential regulatory approvals in the first quarter.

VLA2001 is also being evaluated in elderly and adolescent volunteers. The company expects to report topline data for the elderly trial in the coming weeks.

The stock was up 2.57% at $39.56 in premarket trading.

Biohaven Preannounces Strong Q4 Product Revenue

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced preliminary fourth-quarter net product revenue from Nurtec ODT of $190 million.

The migraine preventative drug approved in early 2020 fetched full-year sales of $462 million.

The stock was moving up 6.17% to $131.50 in premarket trading.

Offerings

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) said it has entered into securities purchase agreements with several institutional and accredited investors to issue, in a private placement priced at-the-market under Nasdaq rules, 12.11 million shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 12.11 million shares of common stock, at a purchase price of 95 cent per share of common stock (or pre-funded warrant) and associated warrant, for expected gross proceeds of about $11.5 million.

The stock was slumping 22.86% to 81 cents in premarket trading.

Click here to access Benzinga’s FDA Calendar.

Clinical Readouts/Presentations

Avalo Therapeutics, Inc. (NASDAQ: AVTX) will host a virtual investor day, from 8 a.m. to 10 a.m. At the event, the company will provide updates on the Phase 1b proof-of-concept study of AVTX-002 in Crohn’s disease, the AVTX-007 development program for multiple myeloma and adult-onset Still’s disease and the AVTX-803 development program for leukocyte adhesion deficiency type II.

Lipocine Inc. (NASDAQ: LPCN) will present a poster at the 2022 NASH-TAG Conference in Park City, Utah, Phase 2 data for LPCN 1144 in non-alcoholic steatohepatitis.

Earnings

AngioDynamics, Inc. (NASAQ: ANGO) (before the market open)

Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates


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